Not Authorised Therapeutic confirmatory (Phase III) chronic active Staphylococcus aureus mono-infection/asymptomatic carriage in the nasal cavity

Clinical trial confirming the efficacy of 1.8-cineole (18C) in the treatment of MRSA staphylococcal carriage

EU CTIS ID: 2025-521569-29-00

What this study is testing

The main objective of the study is the evaluation of the effectiveness of 1,8-cineole treatment of the MRSA bacterial nasal cavity infections. Evaluation will be carried out by microbiological examination (nasal cavity culture) immediately after 7 days of therapy.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Willing and able to give informed consent to participate in the study.
  • Patients aged between 18 and 70 years with positive nasal swabs for MRSA strains.
  • Presence of MRSA strains in nasal swab cultures taken at the first initial screening visit (V0).
  • Patients willing to avoid pregnancy or paternity based on the following criteria: a) a woman who is incapable of having children (after surgery to remove the uterus or bilateral ovaries, or after menopause, defined as a period of at least at least 12 months since the last menstrual period) is exempt from pregnancy tests, b) a woman capable of having children with a negative pregnancy test result prior to day 1 dosing and who agrees to take cyclic pregnancy tests according to the study protocol and to take appropriate contraceptives up to one month after the end of treatment, c) a man who agrees to take appropriate precautions to avoid paternity (with at least 99% certainty) and/or to refrain from donating sperm from the screening visit until 30 days after treatment.

You likely can't join if

  • Pregnant or breastfeeding women.
  • An illness or medical, physical or mental condition of the subject that, in the opinion of the investigator, would interfere with full participation in the study (for example administration of the study drug or attendance at required study visits), or pose a significant risk to the subject or interfere with the interpretation of data from the study.
  • Use of the investigational medicinal product within 30 days prior to inclusion in the study.
  • Hypersensitivity or allergy to mupirocin, 1,8-cineole, and/or any of the ingredients of the investigational medicinal product.
  • Contraindication to endoscopic examination of the nasal cavity.
  • Use of other intranasal preparations.
See the full eligibility criteria
Who can join
  • Willing and able to give informed consent to participate in the study.
  • Patients aged between 18 and 70 years with positive nasal swabs for MRSA strains.
  • Presence of MRSA strains in nasal swab cultures taken at the first initial screening visit (V0).
  • Patients willing to avoid pregnancy or paternity based on the following criteria: a) a woman who is incapable of having children (after surgery to remove the uterus or bilateral ovaries, or after menopause, defined as a period of at least at least 12 months since the last menstrual period) is exempt from pregnancy tests, b) a woman capable of having children with a negative pregnancy test result prior to day 1 dosing and who agrees to take cyclic pregnancy tests according to the study protocol and to take appropriate contraceptives up to one month after the end of treatment, c) a man who agrees to take appropriate precautions to avoid paternity (with at least 99% certainty) and/or to refrain from donating sperm from the screening visit until 30 days after treatment.
What rules you out
  • Pregnant or breastfeeding women.
  • An illness or medical, physical or mental condition of the subject that, in the opinion of the investigator, would interfere with full participation in the study (for example administration of the study drug or attendance at required study visits), or pose a significant risk to the subject or interfere with the interpretation of data from the study.
  • Use of the investigational medicinal product within 30 days prior to inclusion in the study.
  • Hypersensitivity or allergy to mupirocin, 1,8-cineole, and/or any of the ingredients of the investigational medicinal product.
  • Contraindication to endoscopic examination of the nasal cavity.
  • Use of other intranasal preparations.
  • Patients requiring treatment with antibiotic or systemic corticosteroids.
  • Past surgery in the nasal cavity or paranasal sinuses within the last 6 months.
  • Presence of cystic fibrosis or ciliary dyskinesia.
  • Presence of active cancer.
  • Immunodeficiency.
  • Past or current participation in another clinical trial within the past 3 months.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.